Guidezilla™ II H74939335150610Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 08714729939467), received between Sep 4, 2018 and Aug 19, 2026 — classified as 2 deaths, 7 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (30 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Nonstandard Device; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331343 ↗
• InjuryAug 5, 2026Failure to Advance

  It was reported that additional intervention was required. A 6F Guidezilla II was selected for use in the left coronary artery. During the procedure, it was noted that the catheter tip could not cross the left coronary lesion. The device was removed with the help of a balloon. The procedure was completed with another of the same device. There were no patient complications, and the patient condition following procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147007 ↗
• MalfunctionMay 6, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16APR2026. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS LESION. THE 71% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID-LEFT CIRCUMFLEX ARTERY. A GUIDEZILLA II CATHETER-GUIDE EXTENSION WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT IS FINE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COLLAR AND SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107661 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE IN THE ANTERIOR DESCENDING BRANCH. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815587 ↗
• InjuryApr 1, 2026Nonstandard Device; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COLLAR WAS DAMAGED. THE SEVERELY VASCULAR STENOSED TARGET LESION WAS LOCATED IN A 90% OF TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 6F LONG GUIDEZILLA II CATHETER-GUIDE EXTENSION WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT THE METAL CONNECTION PART BETWEEN THE SHORT TRANSITION SECTION OF THE HYPOTUBE AND THE VISIBLE SPIRAL SLEEVE RING WAS KINKED AND COULD NOT CROSS A NON-BOSTON SCIENTIFIC STENT. THE DEVICE WAS REMOVED FROM THE PATIENT USING A BALLOON-ANCHORED GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757281 ↗
• MalfunctionMar 26, 2026Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. A 6F GUIDEZILLA II WAS SELECTED FOR USE AT THE ANTERIOR DESCENDING BRANCH, ANTERIOR SEGMENT. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE CONNECTING PIPE SEGMENT BECAME LOOSE, CAUSING THE GUIDEWIRE AND DEVICE TO BECOME STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706042 ↗
• MalfunctionFeb 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 6F GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. UPON UNPACKING, OUTSIDE THE PATIENT, PRESENCE OF FOREIGN MATTER IN THE BAG WAS OBSERVED. THERE WERE NO COMPLICATIONS AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370066 ↗
• MalfunctionFeb 16, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. A 6F LONG GUIDEZILLA II WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT A CATHETER FRACTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE CONDITION OF THE PATIENT POST PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349321 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 97% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, THE SHAFT CONNECTION WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23910906 ↗
• MalfunctionDec 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE FRONT END OF THE DEVICE RUPTURED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED HEART. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE CONNECTION AT THE TIP WAS RUPTURED. THE DEVICE WAS REMOVED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885150 ↗
• MalfunctionDec 18, 2025Break; Obstruction of Flow; Break; Obstruction of Flow

  IT WAS REPORTED THAT THE GUIDEZILLA WAS FRACTURED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 6F GUIDEZILLA CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT UPON FLUSHING THE LUMEN OF THE GUIDEZILLA, AN OBSTRUCTION WAS FOUND. WHEN THE GUIDE CATHETER WAS INSERTED, THE TIP WAS FOUND TO BE FRACTURED IN HALF BUT NOT ENTIRELY DETACHED. THE DEVICE WAS SLOWLY REMOVED ALONG THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845934 ↗
• MalfunctionDec 10, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A TIP FRACTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 6F GUIDEZILLA II WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS FRACTURED. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT IS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766435 ↗
• MalfunctionNov 17, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 23OCT2025. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 97% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOSITY AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE COLLAR AND SHAFT SEPARATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575944 ↗
• MalfunctionNov 4, 2025Device Damaged by Another Device; Device-Device Incompatibility; Device Damaged by Another Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COLLAR WAS CRACKED. THE PATIENT WAS PRESENTED WITH A CORONARY ATHEROSCLEROTIC HEART DISEASE AND UNSTABLE ANGINA AND UNDERWENT A CORONARY STENT IMPLANTATION AND PERCUTANEOUS CORONARY BALLOON DILATION ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS 80% STENOSED, PROXIMALLY DIFFUSED AND CALCIFIED. 99% SUBTOTAL OCCLUSION WAS ALSO NOTED IN THE MID RIGHT CORONARY ARTERY. A 6F LONG GUIDEZILLA II CATHETER GUIDE EXTENSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COLLAR OF THE DEVICE HAD A CRACK AT THE CONNECTION, AND A QUALITY ISSUE WAS SUSPECTED. THE DEVICE WAS REMOVED NORMALLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT REMAINED STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467314 ↗
• MalfunctionOct 31, 2025Nonstandard Device; Device Damaged by Another Device; Device-Device Incompatibility; Difficult to Advance; Nonstandard Device; Device Damaged by Another Device; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE COLLAR WAS DAMAGED. THE GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. A BALLOON CATHETER COULD NOT REACH THE LESION THROUGH THE EXTENSION CATHETER AS THERE WAS A COLLAPSE AT THE CONNECTION POINT OF THE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434545 ↗
• MalfunctionOct 23, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30SEP2025. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 6F LONG GUIDEZILLA II WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS GOOD POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PARTIAL COLLAR AND SHAFT SEPARATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372403 ↗
• MalfunctionOct 21, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Material Integrity Problem; Break; Deformation Due to Compressive Stress; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT A KINKED AND FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING BRANCH. A 6F LONG GUIDEZILLA II WAS USED FOR TREATMENT. THE SURFACE OF THE GUIDEZILLA WAS NOT SMOOTH. DURING THE PROCEDURE, THE DEVICE GOT KINKED AND FRACTURED BEFORE REACHING THE LESION. THE DEVICE WAS REMOVED WITH COMPLICATIONS REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345643 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24SEP2025. IT WAS REPORTED THAT THE TIP WAS KINKED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 6F GUIDEZILLA II WAS SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THE TIP GOT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT IS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COLLAR AND SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304308 ↗
• MalfunctionSep 30, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 6F GUIDEZILLA CATHETER GUIDE EXTENSION WAS SELECTED FOR USE. IT WAS NOTED THAT DEVICE WAS CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS FURTHER REPORTED THAT THERE WAS NO DEVICE ISSUE. PRIOR TO THE PROCEDURE, USER HANDLING RESULTED IN THE DEVICE BECOMING CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23184644 ↗
• MalfunctionJul 24, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 6F GUIDEZILLA CATHETER GUIDE EXTENSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW EXTENSION CATHETER. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS FOLDED IN HALF BUT DID NOT BREAK. IT WAS COMPLETELY REMOVED BY SIMPLY PULLING IT FROM THE BODY OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22603520 ↗
• DeathJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT WAS ADMITTED FOR AN ELECTIVE CORONARY ANGIOGRAM FOLLOWING A POSITIVE CT CORONARY ANGIOGRAM (CTCA). THE PROCEDURE WAS INITIATED VIA RIGHT RADIAL ARTERY ACCESS, AND A 7F NON-BOSTON SCIENTIFIC RADIAL SHEATH WAS INSERTED. ANGIOGRAPHY REVEALED SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY LESIONS, WHICH WAS ALSO NOTED TO BE MODERATELY TORTUOUS. A 6F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS ENGAGED TO ASSIST DEVICE ADVANCEMENT. ROTATIONAL ATHERECTOMY WAS PERFORMED USING A 1.50 MM ROTAPRO DEVICE. INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN PERFORMED FOLLOWED BY MULTIPLE BALLOON INFLATIONS WITH 3.00MM X 15MM, 2.75MM X 12MM AND 2.50MM X 12MM NC EMERGE BALLOON CATHETERS. THE BALLOON INFLATIONS WERE CARRIED OUT IN THE PROXIMAL AND MID-LAD SEGMENTS. DURING THIS PROCESS, HYPOTENSIVE EPISODES WERE OBSERVED AND MANAGED WITH MULTIPLE ARAMINE BOLUSES. A 2.50 X 32 MM SYNERGY XD DRUG-ELUTING STENT WAS THEN ADVANCED DOWN THE LAD. WHILE OPTIMAL POSITIONING WAS PERFORMED, THE STENT SHAFT WAS SHEARED, NOTED POSSIBLY DUE TO CONTACT WITH HEAVILY CALCIFIED PLAQUE. A PORTION OF THE SHAFT, INCLUDING THE UNDEPLOYED STENT AND STENT BALLOON, BECAME DET

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 22248440 ↗
• MalfunctionJun 3, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09MAY2025. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION DUE TO ANGULATION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. A 6F GUIDEZILLA II CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION DUE TO ANGULATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS IN GOOD CONDITION POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COLLAR AND SHAFT DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136604 ↗
• InjuryJun 2, 2025Break; Break

  IT WAS REPORTED THAT DEVICE SEPARATION OCCURRED AND IT WAS REMOVED WITH A SNARE. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 6F LONG GUIDEZILLA II WAS SELECTED FOR USE. DURING WITHDRAWAL, IT WAS NOTED THAT SEPARATION OCCURRED AT THE BORDER OF THE COLORED PART OF THE DEVICE DUE TO SEVERE TORTUOSITY. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENTS BODY USING A SNARE AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128744 ↗
• MalfunctionMay 9, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COLLAR DETACHMENT OCCURRED. THE 93% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED HEART ARTERY. A 6F GUIDEZILLA II CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WELDING JOINT OF THE DEVICE WAS FRACTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY BY SIMPLY BEING PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998895 ↗
• MalfunctionMar 17, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25FEB2025. IT WAS REPORTED THAT DIFFICULT TO ADVANCE OCCURRED. A 6F LONG GUIDEZILLA II WAS SELECTED FOR WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT IT WAS UNABLE TO GET PROMUS ELITE STENT THROUGH THE GUIDEZILLA GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PARTIAL COLLAR AND SHAFT SEPARATION WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618784 ↗